OQ procedure AS 110, edition 1
Contents
1. Antec Industrieweg 12 2382 NV Zoeterwoude The Netherlands For AS 110 autosampler 191 0022 Edition 1 2013 ISO 9001 T 31 71 5813333 F 31715813334 info myantec com www myantec com certified Copyright 2013 Antec The Netherlands Contents of this publication may not be reproduced in any form or by any means including electronic storage and retrieval or translation into a foreign language without prior agreement and written consent from the copyright of the owner The information contained in this document is subject to change without notice ROXY ALEXYS DECADE DECADE II INTRO Flexcell SenCell ISAAC HyREF are trademarks of Antec Whatman word and device and Whatrnan word only are trademarks of Whatman International Ltd SOLVENT IFD and AQUEOUS IFD are trademarks of Arbor Technologies Inc Clarity DataApex are trademarks of DataApex Ltd Microsoft and Windows are trademarks of Microsoft Corporation Excel is a registered trademark of the Microsoft Corpora tion The software and the information provided herein is believed to be reliable Antec shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing performance or use of software or this manual All use of the software shall be entirely at the user s own risk Chapter 1 Symbols 1 of 24 Explanations of symbols amp labels on the device or in user manua2. column Results Specified Measured Result HPLC TESTS Column test Plate number gt 1500 asas aerua Retention time lt 5 min MIN v eee eee Signal Height Pa EN nA NAS eadera Repeatability RSDt lt 05 J ann Yo E RSD area lt 30 J aan Yo E eens Linearity Correlation coefficient r gt 0 997 sanasana ee Specifications for some of the HPLC tests are hardware dependent check the applicable specs on page 18 of document p n 180 0028 PQ for HPLC ECD systems Verified by customer eecececeeeesererererenn Deviations Y N Comments Chapter 3 Repeatability amp Linearity test 19 of 24 What to do if the OQ failed Steps to take when the AS 110 auto sampler fails the OQ test 1 Finish the OQ as far as possible If one section is failed it may very well be that also other tests will fail that will help in finding the problem In case tests are failed fill in a non conformance report for every failed test 2 Find the corresponding sections in the service documentation and see what test recommendations and fixes are given to solve the problem 3 If not successful in fixing the problem contact Antec for service or further instructions 20 of 24 OQ procedure AS 110 edition 1 CHAPTER 4 OQ certification The Operational Qualification has been carried out in accordance to the OQ procedure and has been carried out to the satisfaction of both parties All tests as des
3. Tray needle alignment wizard and follow the instructions on the PC screen Use a flash light to locate and illuminate the alignment notches in the black tray table as they are very small e Continue with the Wash position alignment and follow the instruc tions on the PC screen e Continue with the syringe home position alignment and follow the instructions on the PC screen Successful performance if all alignment procedures are completed suc cessfully In case of failure see the AS 110 service manual for directions to remedy the problem Result Passed L Failed Verified by customer c eceeeeeeeeee tees Deviations Y N Comments Chapter 3 Temperature test 15 of 24 Temperature test In the case the auto sampler is equipped with a cooling option the tempera ture test should be executed to check if the cooling system is operating in accordance with the manufacturer s specifications Preparation The environmental conditions should preferably meet a temperature of maximum 24 C and 80 humidity The thermometer should have an accuracy of 0 5 C Procedure e Place the tip of the probe of the thermometer in a vial filled with distilled water e Place the vial in the 48 vial adapter in one of the positions in the front e Close the sample compartment with the isolation cover 16 of 24 OQ procedure AS 110 edition 1 e Set the temperature in ASM direct control to a set point of 4
4. be trained and qualified to perform an OQ on an AS 110 auto sampler Company Performer Title Signature Reviewer customer The undersigned reviewer customer accepts that the above mentioned engineer is trained and qualified to perform an OQ on an AS 110 auto sampler Company Reviewer Customer Title Signature Owner designated authorized person 8 of 24 OQ procedure AS 110 edition 1 Instruments O AS110 p n s n L AS 110 micro p n s n O Cooling option L 10 port valve AS software version ASM version Manufacturer Antec Supplier Date of delivery Warranty until In case a 10 port valve is installed with a dual loop configuration in the auto sampler flow path please reconfigure the flow path to a single loop configuration to be able to perform the reproducibility test See document p n 181 7032 10 port to 6 port valve changer kit Verified by customer eceeeeeeeeeeeeee Deviations Y N Comments Chapter 2 Identification 9 of 24 Test equipment Below an overview of the required tools equipment are listed e Antec Electrochemical detector Intro DECADE DECADE II with Glassy Carbon flow cell e LC pump e Data acquisition software e Temperature sensor with an accuracy of 0 5 C e Alias Service Manager software e PQ for HPLC ECD kit p n 250 3040 e AS 110 needle stripper tool e Small flash light To perform the HPLC tests of the PQ
5. complete OQ for a AS 110 auto sampler consists of Communication test Hardware verification Alignment check amp adjustment Temperature test for auto samplers with cooling option Repeatability amp linearity test OBO O The repeatability amp linearity test is based on the HPLC performance test which is part of the PQ for HPLC ECD systems p n 180 0028 So to execute test 5 all part column MOPEG test sample concentrated buffer of the PQ for HPLC ECD kit p n 250 3040 are required This document guides you a trained and qualified person through the operational qualification of the AS 110 auto sampler The owner s man agement approves the successful completion of this qualification by signing off the OQ certification at the end of this document All qualification checks in this document must be approved or must be marked n a if not applicable Any deviation observed must be document ed in the non conformance record All relevant documents regarding this operational qualification must be filed together in one location As regulations and customer requirements may change manufacturer reserves the right to introduce changes without prior notice For details on functionality operation and theory references are made to the instrument user manual 6 of 24 OQ procedure AS 110 edition 1 Chapter 2 Identification 7 of 24 CHAPTER 2 Identification Engineer The undersigned engineer certifies to
6. 2O and 20 IPA e Select in the section Initial wash the Start button check if the complete flow path will be filled with wash solvent and no air bub bles are remained in the flow path e Check the AS flow path for visual leakage Successful performance no positioning errors and no air bubbles or leak age visible in the flow path In case of failure see the AS 110 service man ual for directions to remedy the problem Result Passed L Failed Verified by customer cece ees Deviations Y N Comments Chapter 3 Alignment check amp adjustment 13 of 24 Alignment check amp adjustment In this procedure the following adjustments are checked using the ALIAS service manager and can be re adjusted if required e Needle tray adjustment e Wash position adjustment e Syringe home position For detailed instructions see chapter 7 of document 191 0020 AS 110 ser vice manual Main adjustments Wash position alignment Syringe adjustment al Up Left A Right i lt gt Adjustment order requires 7 steps to complete Click start button to start Tray needle alignment PP ee we Front rears mn Left right 2 25_ Bf mm i jso Sf dui J Ey amp Le fos gi Frontier 2 25 fim Levan eso gj mam 14 of 24 OQ procedure AS 110 edition 1 Execute the following steps e Open ASM service menu and go to the service menu e Select the option main adjustments e Start the
7. C and switch the cooling on If the environmental temperature is 24 C or higher execute the T test at a SET temperature that is 20 C below the room temperature room temperate 26 C gt set point 6 C etc e Let the cooler stabilize a while f e 15 min and measure the tem perature repeat if necessary Stabilization will take a while but should not take longer than 1 hour e Record the actual temperature of the temperature probe The specification of the temperature accuracy of the temperature within the sample compartment is set point 2 C So in case of a successful tem perature test the actual temperature after stabilization should be within 4 2 Result Passed L Failed Chapter 3 Temperature test 17 of 24 Verified by customer 0 cceeeeeeeeeeeeee Deviations Y N Comments 18 of 24 OQ procedure AS 110 edition 1 Repeatability amp Linearity test To execute this test the following documentation is required Q 1 p n 180 0028 PQ for HPLC ECD systems 2 p n 180 0028C PQ appendices Furthermore the parts column MOPEG test sample concentrated buffer and tubing of the PQ for HPLC ECD kit p n 250 3040 are re quired to perform the test Execute the test procedure as described in chapter 4 HPLC performance test in document p n 180 0028 PQ for HPLC ECD systems Write the rele vant test results down in the table and indicate passed or failed in the last
8. a kit can be ordered that contains the test substance the column concentrated mobile phase and tubing connections for the part between the injector and flow cell see table be low After use the test substance and concentrated mobile phase can be reordered with the info from the table below but the tubing and column can be reused when taken proper care of Contents of PQ for HPLC ECD kit p n 250 3040 Description Part no Qty Fig 1 Part of PQ for HPLC ECD kit 10 of 24 OQ procedure AS 110 edition 1 The following documents should be available on site can be downloaded from the Antec web site www myantec com for the OQ e 180 0028 PQ for HPLC ECD systems e 180 0028C PQ appendices e 193 0020 AS 110 service manual Instruments amp Test materials Pump Type Serial number Acquisition software Type Serial number Revision Detector Type Serial number Calibration date sis Flow cell Type WE diameter REF electrode Serial number Temperature sensor Type Serial number Calibration date Column for PQ Type eee Serial number 2 uM MOPEG solution Lot number Expiration date Mobile phase for PQ Lot number Expiration date Verified by customer eeseseceeeeserererereee Deviations Y N Comments Chapter 3 Communication test 11 of 24 CHAPTER 3 Communication test Execute the following steps to check the communication and verify the instrument configur
9. ation e Connect the serial communication cable e Start ASM software e Select Communication and select the correct com port of the PC e Select Alias Direct control e Initialize the instrument and check if the Status of the instrument will be displayed Idle e Check Software version System boot ID and Serial number stalled options are matching with the selectable options in the direct con trol window Status Idle Software version 1 00 Door Closed System boot ID 1 00 Serial number 50030 e Write down the AS software version on page 6 instruments Successful performance instruments display all requested versions and initialize without any error message In case of failure see the AS 110 ser vice manual for directions to remedy the problem Result Passed L Failed Verified by customer cceeeeeeeee eee eeee Deviations Y N Comments 12 of 24 OQ procedure AS 110 edition 1 Hardware verification e Open ASM direct control and check the following hardware mod ules of the AS 110 Auto sampler e Select in the section Tray the button Front and check if the Tray moves to the front position e Select in the section Valve the button Load and check if the valve is switching from the Inject position to the Load position e Return the valve to the Inject position and check if the flow path is switched as the diagram is displaying e Install the wash bottle preferable with 80 H
10. cribed in this document have been successfully completed and all results are within specifications Executing engineer Antec representative Technician name amp signature Customer authorised to sign Name amp signature Chapter 4 OQ certification 21 of 24 Comments 22 of 24 OQ procedure AS 110 edition 1 CHAPTER 5 Non conformance record Any case of non conformance found during the OQ procedure should be documented and signed for acceptance or corrective action taken Table 2 Non conformance record Ref Non conformance and action taken Signature Sign executing customer technician 1
11. l Symbol A Explanation The caution warning sign denotes a hazard It calls atten tion to a procedure or practice which if not adhered to could result in severe lethal injury or damage destruction of parts or all of the equipment Do not proceed beyond a warning sign until the indicated conditions are fully under stood and met The attention sign signals relevant information Read this information as it might be helpful 2 of 24 OQ procedure AS 110 edition 1 Safety practices The OQ procedure may only be performed by a qualified service engineer trained by the manufacturer The following safety practices protective measures are intended to ensure safe operation of the instrument Electrical hazards Never open a device Removal of protective panels on the instrument can N result in exposure to potentially dangerous voltages which may lead to severe injury or loss of life The instrument may only be opened by au thorized service engineers of the manufacturer or a company authorized by the manufacturer DISCONNECT POWER BEFORE SERVICING AVERTISSEMENT RISQUE DE CHOC ELECTRIQUE COUPER L ALIMENTATION AVANT LA MAINTENANCE A WARNING RISK OF ELECTRIC CHOCK Solvents Organic solvents are highly flammable Since capillaries can detach from N their screw fittings and allow solvent to escape it is prohibited to have any open flames near the analytical system If a leakage occurs tur
12. n of the power of the instrument and remedy the situation immediately Regularly check for leaks and clogged LC tubing and connections Do not close or block drains or outlets Do not allow flamma ble and or toxic solvents to accumulate Follow a regulated approved waste disposal program Never dispose of such products through the mu nicipal sewage system Toxicity Organic solvents are toxic above a certain concentration Ensure that work areas are always well ventilated Wear protective gloves safety glasses and other relevant protective clothing when working on the device Chapter 1 3 of 24 Table of contents Symbols 1 Safety practices 2 Electrical hazards 2 Solvents 2 Table of contents 3 Introduction 5 Identification 7 Engineer 7 Reviewer customer 7 Instruments 8 Test equipment 9 Communication test 11 Hardware verification 12 Alignment check amp adjustment 13 Temperature test 15 Repeatability amp Linearity test 18 What to do if the OQ failed 19 OQ certification 20 Non conformance record 22 4 of 24 OQ procedure AS 110 edition 1 Chapter 1 Introduction 5 of 24 CHAPTER 1 Introduction This document describes the Operational Qualification OQ process for the AS 110 auto sampler as advised by the manufacturer It is the result from our interpretation of many regulations and laboratory practises In addition feedback from users and representatives helped us to finalize this procedure A
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